Amgen Inc Company Profile
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What is the competitive landscape for AMGEN INC
AMGEN INC has five approved drugs.
There are twenty-three US patents protecting AMGEN INC drugs.
There are three hundred and ninety-five patent family members on AMGEN INC drugs in fifty-four countries and sixteen supplementary protection certificates in fifteen countries.
Summary for Amgen Inc
| International Patents: | 395 |
| US Patents: | 23 |
| Tradenames: | 4 |
| Ingredients: | 4 |
| NDAs: | 5 |
| Drug Master File Entries: | 9 |
| Patent Litigation for Amgen Inc: | See patent lawsuits for Amgen Inc |
| PTAB Cases with Amgen Inc as petitioner: | See PTAB cases with Amgen Inc as petitioner |
| PTAB Cases with Amgen Inc as patent owner: | See PTAB cases with Amgen Inc as patent owner |
Drugs and US Patents for Amgen Inc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-002 | Jan 20, 2023 | RX | Yes | Yes | 11,827,635 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Amgen Inc | OTEZLA XR | apremilast | TABLET, EXTENDED RELEASE;ORAL | 210745-001 | Aug 29, 2025 | RX | Yes | Yes | 7,427,638 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | AB | RX | Yes | No | 9,872,854*PED | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | AB | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amgen Inc | OTEZLA XR | apremilast | TABLET, EXTENDED RELEASE;ORAL | 210745-001 | Aug 29, 2025 | RX | Yes | Yes | 10,092,541 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Amgen Inc | CORLANOR | ivabradine | SOLUTION;ORAL | 209964-001 | Apr 22, 2019 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | |||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for Amgen Inc
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | 7,893,101 | ⤷ Start Trial |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 8,802,717 | ⤷ Start Trial |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 7,659,302 | ⤷ Start Trial |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-001 | Mar 21, 2014 | 9,018,243 | ⤷ Start Trial |
| Amgen Inc | CORLANOR | ivabradine | SOLUTION;ORAL | 209964-001 | Apr 22, 2019 | 7,361,649 | ⤷ Start Trial |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-003 | Mar 21, 2014 | 8,455,536 | ⤷ Start Trial |
| Amgen Inc | OTEZLA | apremilast | TABLET;ORAL | 205437-002 | Mar 21, 2014 | 6,020,358 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for AMGEN INC drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 10 mg, 20 mg and30 mg | ➤ Subscribe | 2018-03-22 |
International Patents for Amgen Inc Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2861594 | ⤷ Start Trial |
| European Patent Office | 2295055 | ⤷ Start Trial |
| South Korea | 20240014049 | ⤷ Start Trial |
| Australia | 2018273356 | ⤷ Start Trial |
| Morocco | 48772 | ⤷ Start Trial |
| Costa Rica | 20210665 | ⤷ Start Trial |
| Poland | 3756650 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Amgen Inc Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2962690 | C 2019 032 | Romania | ⤷ Start Trial | PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115 |
| 2962690 | CR 2019 00033 | Denmark | ⤷ Start Trial | PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116 |
| 2962690 | 2019/037 | Ireland | ⤷ Start Trial | PRODUCT NAME: APREMILAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/981 20150115 |
| 2962690 | 37/2019 | Austria | ⤷ Start Trial | PRODUCT NAME: APREMILAST ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/981 (MITTEILUNG) 20150116 |
| 2962690 | 300994 | Netherlands | ⤷ Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
| 2962690 | C20190029 00295 | Estonia | ⤷ Start Trial | PRODUCT NAME: APREMILAST;REG NO/DATE: EU/1/14/981 16.01.2015 |
| 2962690 | CA 2019 00033 | Denmark | ⤷ Start Trial | PRODUCT NAME: APREMILAST ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/981 20150116 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
